Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Improving the psychological wellbeing of family caregivers of home based palliative care patients: A randomised controlled trial

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Scientific title

Evaluating the effect of carer education and support from a palliative care nurse on the psychological wellbeing of family caregivers of home based palliative care patients: A randomised controlled trial

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Universal Trial Number (UTN)

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

General wellbeing / Grief36730

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Carer Preparedness36740

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Condition category

Condition code

Mental Health3839383900

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Studies of normal psychology, cognitive function and behaviour

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Three sessions with a palliative care nurse to provide carers with education and support relating to the role of caring for someone receiving home based palliative care. Sessions are approximately one hour in length and are conducted weekly. During the sessions, carers are provided with a resource pack which includes a family carer guidebook, a relaxation CD, and relevant service brochures. In addition, the nurse also assesses carer needs and develops a care plan to address carer needs.

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Intervention code [1]33880

Behaviour

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Comparator / control treatment

No treatment but access to all of the usual carer services including nursing care and allied health care.

Primary carers of patients who are admitted to home based community palliative care services. Patients must have cancer and a primary caregiver/next of kin (NOK). Carers must be over 18 years and be able to read and write English.

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Minimum age

18Years

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Maximum age

No limit

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Gender

Both males and females

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Can healthy volunteers participate?

No

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Key exclusion criteria

Patients who do not have cancer and/or do not have a primary caregiver/NOK. Carers who are unable to read and write English

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Study design

Purpose of the study

Educational / counselling / training

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Allocation to intervention

Randomised controlled trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Following completion of time 1 data collection, participants are asked to pick an ID number out of an envelope (containing all possible numbers). Each ID number has been pre-allocated to a group.

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

This study will examine the effectiveness of a psycho-educational intervention aimed at promoting coping and psychological wellbeing in family caregivers caring for a relative receiving home based palliative care. The intervention will be offered in a full version (two home visits and one phone call) and the 'rural' format (one home visit and two phone calls). The main hypotheses are:1. Primary family caregivers who receive the intervention will report: increased perceived competence for their caregiving role; increased perceived preparedness for their caregiving role; increased positive emotions associated with their role; decreased unmet informational needs; decreased levels of psychological distress, when compared with caregivers in the control group one week after the intervention.2. Family caregivers receiving the intervention will report decreased levels of psychological distress when compared to controls 3 months following bereavement.